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Menopausal Sleep Fragmentation and Body Fat Gain

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ClinicalTrials.gov Identifier: NCT03047330
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Hadine Joffe, MD MSc, Brigham and Women's Hospital

Brief Summary:
This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.

Condition or disease Intervention/treatment Phase
Menopause Drug: Leuprolide Acetate Other: Fragmented sleep Phase 4

Detailed Description:
While obesity is highly prevalent in midlife and older women, with rates increasing markedly after age 40 and body fat increasing in half of women during and after the menopause transition, factors causing these changes are not well understood. Reduced total sleep time has been shown to adversely impact biomarkers of obesity, but the effect of the highly prevalent menopause-related sleep fragmentation secondary to hot flashes on metabolism and eating behaviors in humans is not known. We will use experimental paradigms to isolate the impact of menopause-related sleep disruption, as well as that of hot flashes and estrogen withdrawal, metabolic biomarkers of body fat gain and on eating behaviors, results of which will inform strategies to prevent body fat gain and improve cardio-metabolic health outcomes in women.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: Unfragmented sleep
All subjects will receive one dose of Leuprolide Acetate and will have some unfragmented sleep periods.
Drug: Leuprolide Acetate
one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression.
Other Name: Lupron

Experimental: Fragmented sleep
All subjects will receive one dose of Leuprolide Acetate and will have some fragmented sleep periods.
Drug: Leuprolide Acetate
one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression.
Other Name: Lupron

Other: Fragmented sleep
Fragmented sleep will be experimentally induced.




Primary Outcome Measures :
  1. Leptin [ Time Frame: 3 days ]
    Within-person change in leptin levels


Secondary Outcome Measures :
  1. Daily Caloric Intake [ Time Frame: 7 days ]
    Within-person change in daily caloric intake



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy premenopausal women 21-45 years old
  • Regular sleep schedule
  • Limited alcohol and caffeine intake
  • Regular monthly menstrual cycles
  • No lifetime history of hot flashes
  • Willingness to use approved methods of contraception during study
  • Not obese
  • Good general health

Exclusion Criteria:

  • Contraindication, hypersensitivity or previous adverse reaction to gonadotropin releasing hormone agonists
  • Pregnancy
  • Breastfeeding
  • Tobacco use
  • Contraindicated systemic hormone medications or centrally active medications
  • Shift workers or recent/expected time zone travel
  • Obstructive sleep apnea
  • Insomnia symptoms
  • Diagnosis of osteoporosis or osteopenia
  • Hypothalamic-pituitary-adrenal axis disorders
  • Diabetes
  • Gastric bypass, metabolic disorders, or other related conditions
  • Abnormalities on screening laboratory tests
  • Substantial hearing impairment
  • Cardiovascular illness
  • Neurological illness
  • Recent psychiatric illness or substance-use disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047330


Contacts
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Contact: Aleta Wiley, MPH 6175259627 awiley1@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Aleta Wiley, MPH       awiley1@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Hadine Joffe, MD MSc Brigham and Women's Hospital

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Responsible Party: Hadine Joffe, MD MSc, Vice Chair for Psychiatry Research, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03047330     History of Changes
Other Study ID Numbers: 2016P002821
1R01AG053838 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hadine Joffe, MD MSc, Brigham and Women's Hospital:
menopause
sleep fragmentation
leuprolide
adipokine
weight gain
leptin

Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents